TMC125-C216: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.
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Purpose
The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: TMC125 Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized, Double-blinded, Placebo-controlled Trial to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an ART Regimen, Including TMC114/RTV and an Investigator-selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options. |
- Evaluation of efficacy, tolerability and safety of TMC125 as part of an antiretroviral therapy containing TMC114/ritonavir and an investigator selected optimized background regimen.
| Enrollment: | 593 |
| Study Start Date: | December 2005 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 001
TMC125 2 x 100 mg tablets b.i.d. / 96 weeks
|
Drug: TMC125
2 x 100 mg tablets b.i.d. / 96 weeks
|
|
Placebo Comparator: 002
Placebo 2 tablets b.i.d. / 96 weeks
|
Drug: Placebo
2 tablets b.i.d. / 96 weeks
|
Detailed Description:
This is a Phase III, randomized, double-blind, placebo-controlled trial to evaluate the long-term efficacy, tolerability, and safety of TMC125 as part of an antiretroviral therapy (ART) regimen containing TMC114/ritonavir (RTV) and an investigator-selected optimized background (OBR) in treatment-experienced HIV-1 infected patients. TMC125 is a non-nucleoside reverse transcriptase inhibitor (NNRTI). TMC114 is a protease inhibitor (PI). In this trial, TMC114 will be given with a low dose of ritonavir (RTV), a protease inhibitor commonly used with other, full dose protease inhibitors to improve activity. Additional assessments to be evaluated in this trial include: changes in the HIV-1 genotype, drug susceptibility, and the population pharmacokinetics of TMC125. A pharmacokinetic substudy will be performed at selected sites. Health-related quality of life will be assessed for patients receiving an antiretroviral therapy containing either TMC125 or placebo. Safety and tolerability will be documented throughout the trial. Six hundred HIV-1 infected patients on a stable but virologically failing regimen will be included in the trial. Patients should have at least 1 documented non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutation (either at screening or from historical genotype reports), an HIV-1 plasma viral load > 5000 RNA copies/mL at screening, and at least 3 documented primary protease inhibitor (PI) mutations. Patients will be randomized in a 1:1 ratio to either TMC125 (200 mg twice daily) or to matching placebo; both in combination with TMC114/RTV (600/100 mg twice daily) and an investigator selected OBR of at least 2 antiretrovirals (ARVs), consisting of nucleoside reverse transcriptase inhibitor(s) (NRTI[s]) with or without enfuvirtide. The trial will involve a screening period of up to 6 weeks, a 48-week treatment period, and a 4 week follow-up period. Patients will take 200 mg oral doses of TMC125 tablets or placebo tablets, twice daily (administered as 2 tablets twice daily, with food) in combination with 600 mg oral doses of TMC114 tablets and 100 mg oral doses of ritonavir (administered as 2 tablets of TMC114 and 1 capsule of ritonavir twice daily, with food). The treatment period is 48 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient has 3 or more primary protease inhibitor mutations
- documented genotypic evidence of resistance to currently available NNRTIs (non-nucleoside reverse transcriptase inhibitors) by having at least 1 NNRTI resistance-associated mutation
- on a stable antiretroviral therapy for at least 8 weeks
- plasma viral load at screening visit > 5000 HIV-1 RNA copies/mL.
Exclusion Criteria:
- Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome)
- Any grade 3 or grade 4 toxicity according to the DAIDS grading scale
- Use of disallowed concurrent therapy
- Any active clinically significant disease
Contacts and Locations More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Compound Development Team Leader TMC125, Tibotec Pharmaceutical Limited |
| ClinicalTrials.gov Identifier: | NCT00255099 History of Changes |
| Other Study ID Numbers: | CR006307, TMC125-C216 |
| Study First Received: | November 15, 2005 |
| Last Updated: | June 2, 2011 |
| Health Authority: | United States: Food and Drug Administration Ireland: Irish Agriculture and Food Development Authority |
Keywords provided by Tibotec Pharmaceuticals, Ireland:
|
HIV HIV-1 TMC125 |
ClinicalTrials.gov processed this record on May 21, 2013